COMPLETED

Red Blood Cell Survival in Sickle Cell Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD is a common treatment. The efficacy of RBC transfusion therapy to treat or prevent complications of SCD may be hampered by variable survival of the transfused donor RBC. The overall aim is to see how long RBC survive in SCD patients who are chronically transfused. When a study participant has a regular blood transfusion the researchers will label a small portion of the RBCs that are transfused with biotin. The participant will return at Day 1, weekly for 3 months and monthly for 3 months to measure how long those RBCs survive. An optional sub-study using INTERCEPT RBCs will mirror the main study but will use INTERCEPT RBCs that have biotinylated for 1 RBC unit.

Official Title

Kinetics of Donor Red Blood Cell Survival in Sickle Cell Disease

Quick Facts

Study Start:2021-10-29
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04426591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hemoglobinopathy:
  2. * Any sickle cell disease genotype, or
  3. * Transfusion-dependent thalassemia (TDT)
  4. * Receiving CTT for ≥3 months prior to enrollment.
  5. * For participants with past BioRBC transfusion exposure, BioRBC antibody screens must have been conducted through at least 6 months post exposure, with negative results.
  1. * Anticipated cessation of CTT in the next ≤2 months
  2. * Ongoing consumption of biotin or raw egg dietary supplements
  3. * Antibody specific of INTERCEPT RBCs at baseline (for subjects consenting to the optional arm)
  4. * BioRBC-specific antibodies ever detected in the past, or detected on post-enrollment screening prior to first infusion of Bio-RBC.

Contacts and Locations

Principal Investigator

Marianne Yee, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Hughes Spalding Children's Hospital
Atlanta, Georgia, 30303
United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, 30322
United States
Grady Health System
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Marianne Yee

  • Marianne Yee, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-29
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2021-10-29
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • Chronic transfusion therapy

Additional Relevant MeSH Terms

  • Sickle Cell Disease